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Int J Stroke. 2015 Oct;10(7):1149-52. doi: 10.1111/ijs.12520. Epub 2015 Jun 4.

Intra-arterial bone marrow mononuclear cells (BM-MNCs) transplantation in acute ischemic stroke (IBIS trial): protocol of a phase II, randomized, dose-finding, controlled multicenter trial.

Author information

1
Department of Neurology, Hospital Universitario Virgen del Rocío, Seville, Spain.
2
Department of Neurology, Hospital Universitario Virgen Macarena, Seville, Spain.
3
Department of Neurology, Hospital Regional de Malaga, Malaga, Spain.
4
Department of Neurology, Hospital Reina Sofia, Cordoba, Spain.
5
Department of Neurology, Hospital Virgen de las Nieves, Granada, Spain.
6
Department of Hematology, Hospital Universitario Virgen del Rocío, Seville, Spain.
7
Department of Radiology, Hospital Universitario Virgen del Rocío, Seville, Spain.
8
Instituto de Biomedicina de Sevilla-IBiS, Hospital Universitario Virgen del Rocío, Seville, Spain.

Abstract

RATIONALE:

No neuroprotective or neurorestorative therapies have been approved for ischemic stroke. Bone marrow mononuclear cell intra-arterial transplantation improves recovery in experimental models of ischemic stroke.

AIMS:

This trial aims to test safety and efficacy of intra-arterial injection of autologous bone marrow mononuclear cell in ischemic stroke patients.

DESIGN:

Multicenter, prospective, phase II, randomized, controlled (non-treated group as control), assessor-blinded clinical trial. Seventy-six stroke patients will be enrolled. Patients fulfilling clinical and radiological criteria (e.g. age between 18 and 80 years, middle cerebral artery ischemic stroke with a National Institutes of Health Stroke Scale score of 6-20 within one- to seven-days from stroke onset and no lacunar stroke) will be randomized to intervention or control group (1 : 1). Bone marrow harvest and intra-arterial injection of autologous bone marrow mononuclear cell will be done in the intervention group with two different doses (2 × 10(6) /kg or 5 × 10(6) /kg in 1 : 1 proportion). Patients will be stratified at randomization by National Institutes of Health Stroke Scale score. Patients will be followed up for two-years.

STUDY OUTCOMES:

The primary outcome is the proportion of patients with modified Rankin Scale scores of 0-2 at 180 days. Secondary outcomes include National Institutes of Health Stroke Scale and Barthel scores at six-months, infarct volume, mortality, and seizures.

DISCUSSION:

This is the first trial to explore efficacy of different doses of intra-arterial bone marrow mononuclear cell in moderate-to-severe acute ischemic stroke patients. The trial is registered as NCT02178657.

KEYWORDS:

bone marrow; cell transplantation; clinical trial; ischemic stroke; mononuclear cell; stem cell

PMID:
26044701
DOI:
10.1111/ijs.12520
[Indexed for MEDLINE]

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